USFDA Current Affairs - 2020

Rapid Antigen Test Kits recommended

On June 15, 2020, the Indian Council of Medical Research recommended the use of Rapid Antigen test kits along with RT-PCR in containment zones.


The Antigen test kits will allow faster diagnosis. They will reduce laboratory examination. The maximum time taken by the Rapid antigen test to interpret positive or negative is 30 minutes.

Recommendations of ICMR

According to ICMR, individuals that test negative to COVID-19 in rapid antigen test should be tested with RT-PCR. On the other hand, individuals testing positive under the rapid antigen test are considered to be positive.

Antigen Test Kits

The Antigen Test kits were developed by a South Korea based company SD Biosensor.

Why SD Biosensor kit was chosen?

The USFDA had earlier authorized US based antigen kit called sofia 2 SARS Antigen kit. Also, Japan had authorized the Fujirebio’s Antigen test kit. However, with tests and analysis conducted by AIIMS and ICMR, India was satisfied with the performance of SD Biosensor antigen kit. The selection was done based on the specificity and sensitivity of the kits.

The specificity of the test is 99.3% to 100%. The sensitivity of the test ranged between 50.6% and 84%.

What is Antigen test?

Just like the RT-PCR test of COVID-19, the antigen testing also looks for virus rather than the antibodies. Antigens are foreign substances that induce immune system in the body.

What is the plan?

The Antigen Test is to be used in three categories as follows

  • Persons showing influenza like symptoms
  • Asymptomatic patients hospitalized for the treatment of malignant disease, immunosuppressed patients, transplant patients, etc.
  • Asymptomatic patients undergoing aerosol and surgical interventions such as surgical procedures, dialysis and bronchoscopy.

Limitations of Antigen test

According USFDA, the antigen testing is not as sensitive as that of RT-PCR testing. The sample collected for COVID-19 testing stays stable only for an hour. Therefore, its is essential to conduct the antigen testing at the  site of sample collection.

USFDA approves emergency use of an investigational vaccine, Remdesivir

The United States Food and Drug Regulatory body recently allowed emergency use of anti-viral investigational vaccine Remdesivir to treat COVID-19 patients.


The USFDA has approved the vaccine after an Indian-American physician, Aruna Subramaninan’s report on Remdesivir. According to the report, the vaccine shortened the recovery times of people that have fallen ill due to COVID-19 virus. The FDA has provided emergency use authorization of the drug.


Remdesivir was developed to treat Ebola virus and Marburg virus. However, it was found to be ineffective in treating these diseases.

International Nonproprietary Name

Remdesivir is an International Nonproprietary Name (INN). The INN is provided to a pharmaceutical drug or active ingredient. The INN is issued in Latin, English, Russian, French, Spanish, Chinese and Arabic.

Emergency Use Authorization

The Emergency Use Authorization in the United States to approve drugs during emergency. Earlier, the US FDA had approved use of diagnostic and therapeutic tools to identify and respond 2009 swine flu outbreak.

In 2013, the FDA issued Emergency Authorization Use of CDC Human Influenza virus.

Remdesivir trial by WHO

WHO had launched 4 mega trials to treat COVID-19. It includes Remdesivir, HCQ (Hydroxychloroquine), combination of Lopinavir and Ritonavir and Interferon-beta along with the combination of Lopinavir and Ritonavir.